FEMALE HEALTH AND EGG QUALITY
RELEASE DATE: June 13, 2002
RFA: HD-02-018
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov/)
LETTER OF INTENT RECEIPT DATE: September 16, 2002
APPLICATION RECEIPT DATE: October 16, 2002
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE
The National Institute of Child Health and Human Development (NICHD) invites
applications from investigators willing to participate in a multisite
National Cooperative Program on Female Health and Egg Quality. This Program
will utilize the cooperative agreement mechanism to try to better understand
the impact of poor nutrition, extreme exercise, smoking, certain assisted
reproductive technologies and other adverse health situations upon
reproductive processes prior to and around the time of fertilization in
females. The central focus of this Program will be to establish measurable or
identifiable characteristics of high quality human and nonhuman eggs that
have full developmental potential. It is thought that a high quality egg is
an important starting point for the development of a healthy embryo, placenta
and fetus. It is also thought that low egg quality can lead to certain forms
of infertility, to abnormal embryonic and fetal development, to low
birthweight as well as to longterm adult diseases and disorders in the
offspring. The Barker Hypothesis on fetal origins of adult diseases suggests
that there can be adverse in utero effects on the fetus that can lead to
certain adult diseases such as heart attacks, diabetes and chronic high blood
pressure. This present initiative is based upon the concept that the Barker
Hypothesis may also pertain to adverse effects on the developing egg before
and around the time of fertilization. Among the ultimate beneficiaries of
this Program will be women who have difficulty attaining healthy pregnancies
and producing healthy offspring owing to low egg quality.
RESEARCH OBJECTIVES
Background
This initiative addresses the idea that low egg quality may be responsible
for difficulties in attaining and maintaining a healthy pregnancy for a
significant number of females. It also addresses the possibility that
certain aspects of egg quality can be affected by adverse health situations
in females prior to or around the time of fertilization. These situations
can include poor nutrition, extreme exercise, smoking and other situations,
including certain assisted reproductive technologies. Recent studies indicate
that 10-15 percent of women of reproductive age seek fertility services in
any given year. In addition, the incidence of infertility appears to be
increasing. There are also data that suggest that numerous adult diseases
and disorders such as heart attacks, diabetes and chronic high blood pressure
may have their origins in low quality eggs owing to exposures of females to
various adverse conditions including poor nutrition, extreme exercise,
smoking and others. These exposures may occur long before fertilization and
may have lasting effects upon egg quality. This research initiative will
test various hypotheses as to the mechanisms that may cause low egg quality
and most importantly, to develop measurable or identifiable characteristics
that can be used to discriminate between eggs of high quality and eggs of low
quality. If the idea is supported by future research, then it is anticipated
that recommendations for female health could be used to prevent or alleviate
some of the adverse outcomes of poor egg quality. Much of this research will
need to be done in nonhuman organisms in order to be able to obtain
sufficient numbers of eggs and also in order to conduct certain in vivo and
in vitro experiments which cannot be done with humans for ethical reasons.
The primary background information for this initiative comes from a
conference held by NICHD on February 28, 2001 on "Effects of Maternal Health
on Reproductive Events Leading to Adult Diseases and Disorders in Offspring."
The distinguished panel of speakers concluded that the biology of human eggs
is poorly understood and that the quality of these eggs may be affected by
many risk factors in human females from their childhood through their
reproductive years. As a result, the panel suggested that basic and clinical
studies be done on the preconceptual and periconceptual health of girls and
women and its potential impact upon egg quality. In addition, the panel felt
that the impact upon egg quality should be followed for its effects on embryo
and fetal development and even into adulthood. The panel also noted that
decreased fertility, abnormal embryo and fetal development, low birthweight
as well as diseases covered under the Barker Hypothesis, may also be caused
by low quality eggs. There is evidence in support of this concept from
nutritional studies in livestock and rodents as well as evidence on decreased
fertility and fecundity in humans that is linked to poor nutrition, extreme
exercise, smoking or other factors. The 2001 Surgeon General"s Report on
Women and Smoking notes that women smokers may have certain unique problems
related to reproductive health. These include increased risk of delayed
time-to-pregnancy, and a moderately increased risk for ectopic pregnancies
and spontaneous abortions. These risks may be related to egg quality that is
compromised in women who smoke prior to or around the time of fertilization.
There are other well-known risks of smoking during pregnancy to women and
their fetuses.
In this special program, major emphasis will be placed upon the determination
of a number of measurable or identifiable characteristics that could be used
to evaluate the quality of individual human oocytes or eggs. These
characteristics will be used as baseline information in the study of the
impact of a variety of preconceptual and periconceptual female health
situations upon egg and preimplantation embryo quality and possible longterm
effects of these situations. It is anticipated that this initiative will
result in an increase in our knowledge of the genetics, cell and molecular
biology of human and other mammalian oocytes and eggs. Substantial
improvements in the culture conditions for the growth and development of
immature oocytes into mature eggs are also expected. One important but
largely unexplored feature of egg quality is the power of the egg cytoplasm
to reprogram gamete or somatic cell nuclei. Using nonhuman species, there
are significant opportunities within this program to study this impressive
ability.
Objectives of this Research Program
o To establish measurable or identifiable characteristics of high quality
human and nonhuman oocytes and eggs
o To better understand how adverse female health situations can result in the
formation of low quality oocytes, eggs and preimplantation embryos
o To understand how low quality oocytes, eggs or preimplantation embryos can
result in longterm adverse outcomes in offspring derived from those oocytes,
eggs or preimplantation embryos
o To determine whether nutritional or other behavioral approaches could be
used to prevent or alleviate some of the causes of low quality eggs and
preimplantation embryos
Research Scope
Examples of research and experimental approaches that are being sought to
achieve the objectives include, but are not limited to, the following:
o To develop baseline criteria that can be used to determine the quality of
individual human oocytes or eggs
o To reveal the elements or mechanisms in oocyte or egg cytoplasm that
control nuclear reprogramming of gametes or somatic cells including nonhuman
embryonic stem cells
o To understand the roles of egg polarity and cytoplasmic localizations in
the formation of high quality mammalian eggs and early embryos, or possible
longterm effects of abnormal egg polarity
o In vivo and in vitro experiments designed to test the hypothesis that poor
nutrition or other adverse female health situations can lead to low quality
oocytes and eggs that can have a longterm impact even into the adulthood of
the offspring (nutrition, smoking, extreme exercise, certain assisted
reproduction protocols, etc.)
o Adverse preconceptual and periconceptual female health situations that may
cause abnormal genomic imprinting with longterm effects, or gender specific
effects
o To study the impact of maternal diabetes upon egg quality
o The study of oocytes raised or matured in vitro compared with naturally
ovulated eggs
o The improvement of oocyte and fertilization culture conditions
o To obtain characteristic gene expression profiles of high and low quality
oocytes and eggs
o Investigation of adverse health situations that can lead to defects in the
meiotic process in oocytes
o The establishment of a panel of proteins or other measurable factors
secreted by high quality and low quality oocytes, eggs or preimplantation
embryos
o Determine the role of companion somatic cells in the formation of healthy,
developmentally competent oocytes
o What are the egg properties that are essential for normal fertilization and
egg activation?
MECHANISM OF SUPPORT
This RFA will use the NIH Cooperative Research Project (U01) award mechanism.
As an applicant you will be solely responsible for planning, directing and
executing the proposed project. The anticipated award date is September 1,
2003. This RFA uses just-in-time concepts.
The NIH U01 is a cooperative agreement award mechanism in which the Principal
Investigator retains the primary responsibility and dominant role for
planning, directing and executing the proposed project, with NIH staff being
substantially involved as a scientific/programmatic partner with the
Principal Investigator during the performance of the activity. Details of the
responsibilities, relationships and governance of the studies to be funded
under this cooperative agreement program are discussed below under
"Cooperative Agreement Terms and Conditions of Award."
It is not known at this time whether this RFA will be reissued in the future.
FUNDS AVAILABLE
The NICHD intends to commit approximately $2 million in total costs [Direct
plus Facilities and Administrative (F & A) costs] in FY 2003 to fund four to
five new and/or competitive continuation grants in response to this RFA. An
applicant may request a project period of up to five years and a budget for
direct costs of up to $300,000 per year. Because the nature and scope of the
proposed research will vary from application to application, it is
anticipated that the size of each award will also vary. Although the
financial plans of NICHD provide support for this program, awards pursuant to
this RFA are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are encouraged to
apply.
SPECIAL REQUIREMENTS
Minimum Application Requirements
o A competent, experienced Principal Investigator who is committed to
investigation of these problems and who is willing to cooperate with the
other Principal Investigators and the NICHD Research Coordinator
o Agreement to participate in Steering Committee meetings that will be held
three times a year
o Experience with analyzing, characterizing, localizing, and/or measuring
biological molecules and investigating oocytes, eggs and/or preimplantation
embryos
o Access to properly managed animal colonies with breeding capabilities
and/or access to human specimens or tissues
o For those with access to human specimens or tissues appropriate for this
project, the applicant must be experienced with prospective and retrospective
analyses of adverse health situations, having demonstrated knowledge of
appropriate methodologies for clinical design and analyses
Meetings
Principal Investigators are expected to attend three Steering Committee
meetings of two days each per year. Funds for attending these meetings should
be included in the budget requests. The first meeting will be a planning
meeting that will be held in Bethesda, Maryland in September, 2003.
Cooperative Agreement Terms and Conditions of Award
The following terms and conditions of the cooperative agreement award and
details of the arbitration procedures pertaining to the scope and nature of
the interaction between the NICHD and the participating awardees will be
incorporated into the Notice of Grant Award and provided to the Principal
Investigator and the institutional official at the time of award. The special
Terms and Conditions of Award are in addition to, not in lieu of, otherwise
applicable OMB administrative guidelines, HHS grant administration
regulations at 42 CFR Parts 74 and 92, and other HHS, PHS and NIH grant
administration policies.
The administrative funding instrument used for this program will be the U01,
an "assistance" mechanism (rather than an "acquisition" mechanism), in which
substantial NIH scientific and/or programmatic involvement with the PI is
anticipated during performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and/or stimulate the PI"s activities
by involvement in and otherwise working jointly with the PI in a partnership
role, it is not to assume direction, prime responsibility, or a dominant role
in the activities. Consistent with this concept, the dominant role and prime
responsibility resides with the PI for the project as a whole, although
specific tasks and activities may be shared between the awardee and the NICHD
Research Coordinator. Facilities and Administrative cost (indirect cost)
award procedures apply to cooperative ageements in the same manner as for
grants. Business management aspects of these awards will be administered by
the NICHD Grants Management Branch in accord with HHS, PHS and NIH grant
administrative requirements.
1. The Primary Rights and Responsibilities of the Awardees
The PI will coordinate project activities scientifically and administratively
at the awardee institution and at other sites that may be supported by
subcontracts to this award. The PI will have primary responsibility for
defining the details of the project within the guidelines of RFA HD-02-018,
and for performing the scientific activities. The PI will agree to accept
close coordination, cooperation and participation of the NICHD Research
Coordinator and the Steering Committee in the scientific and technical
management of the project.
Specifically, the awardee will:
o Determine experimental approaches, design protocols and direct experiments
in consultation with the NICHD Research Coordinator and the Steering
Committee and the awardee will constitute one vote in the group process,
o Analyze and interpret the results
o Present results and plans at Steering Committee meetings
o Accept and implement the common guidelines and procedures approved by the
Steering Committee
o Publish results
o Modify, delete or add protocols within the scientific scope of the project
o Accept and participate in the cooperative nature of the group process
Awardees will retain custody of, and primary rights to, their data developed
under these awards, subject to Government rights of access consistent with
current HHS, PHS and NIH policies.
2. NICHD Responsibilities
NICHD Research Coordinator:
The NICHD Research Coordinator will be a staff member of the Reproductive
Sciences Branch. The Research Coordinator will have a substantial
scientific/programmatic involvement that includes facilitating the
partnership between NIH and the proposed research projects, helping to
integrate the project"s activities with new and emerging research
opportunities, and ensuring that the project"s activities are consistent with
the mission of NICHD. The Research Coordinator will help to maintain
scientific balance between accomplishing goals and addressing emerging
research opportunities. The role of the NICHD Research Coordinator will be
to facilitate, but not to direct activities. It is anticipated that
decisions will be reached through consensus with the PI through the Steering
Committee.
The NICHD Research Coordinator will:
o Ensure that Steering Committee meetings are held on schedule, attend those
meetings and constitute one vote in the group process
o Participate in the development of optional approaches and protocol designs
(and adjustments of protocols and approaches when needed), the Research
Coordinator will assist and facilitate the process, rather than direct it
o Assist and review all phases of the study to assure consistency of protocol
compliance, to improve and strengthen cooperation between the sites, and to
help redirect efforts, or to recommend modification or termination of a site,
when performance requirements are not met
o Participate in data analyses, interpretations and, when warranted,
publication of study results
The above responsibilities are in addition to, not in lieu of, the levels of
involvement normally required for program stewardship of grants.
NICHD Project Officer:
NICHD will appoint a Project Officer, apart from the Research Coordinator,
who will:
o Ensure that all regulatory, fiscal and administrative matters are handled
according to NIH guidelines
o Will evaluate requests for additional funds or for rebudgeting
o Carry out continuous review of individual projects to evaluate progress
o Perform other duties required for normal program stewardship of grants
3. Collaborative Responsibilities
Guidance and Management Structure:
The overall guidance and management of the program will be provided by a
Steering Committee consisting of the Principal Investigators of each of the
participating sites, one staff member of the Reproductive Sciences Branch,
NICHD, who will serve as the Research Coordinator, and one of the Principal
Investigators who will serve as a Chairperson for Steering Committee
meetings. Each Principal Investigator will have one vote and the Research
Coordinator will have one vote. The Steering Committee will be the main
governing body of the projects to be funded by RFA HD-02-018. It will
oversee and coordinate interactions among the projects, and will mediate
interactions between the projects and the NIH. The Steering Committee will
discuss scientific goals and progress, and recommend further research
activities based upon research findings of ongoing projects.
4. Arbitration Process
When agreement between an awardee(s) and NICHD staff cannot be reached on
scientific/programmatic issues that may arise after the award, an arbitration
panel will be formed. The panel will consist of one person selected by the
Principal Investigator(s), one person selected by NICHD staff, and a third
person selected by these two members. The decision of the arbitration panel,
by majority vote, will be binding. This special arbitration procedure will
not, in any way, affect the right of an awardee to appeal an adverse action
in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS
regulations at 45 CFR Part 16.
WHERE TO SEND INQUIRIES
NICHD encourages inquiries concerning this RFA and welcomes the opportunity
to answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Richard J. Tasca, Ph.D.
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6973
FAX: (301) 580-2389
Email: rt34g@nih.gov
o Direct your questions about peer review issues to:
Robert H. Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: rs365f@nih.gov
o Direct your questions about financial or grants management matters to:
Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-5482
FAX: (301) 480-4782
Email: kh47d@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows NICHD staff to estimate the potential review workload and
plan the review.
The letter of intent is to be sent by the date listed at the beginning of
this document. The letter of intent should be sent to:
Richard J. Tasca, Ph.D.
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6973
FAX: (301) 580-2389
Email: rt34g@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 435-0714,
Email: GrantsInfo@nih.gov.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed, photocopies, in
one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application as well
as any appendix material must be sent to:
Robert H. Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: rs365f@nih.gov
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of this RFA. If an application is
received after that date, it will be returned to the applicant without
review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by NICHD. Incomplete and/or non-responsive applications will
be returned to the applicant without further consideration. Applications that
are complete and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by NICHD in
accordance with the review criteria stated below. As part of the initial
merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Child Health and
Human Development Council
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of your application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these
goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application"s overall score, weighting them as appropriate
for each application. Your application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example, you may propose to carry out
important work that by its nature is not innovative but is essential to move
a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the aims
of your application are achieved, how do they advance scientific knowledge?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider alternative
tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans, animals,
or the environment, to the extent they may be adversely affected by the
project proposed in the application
o INCLUSION: The adequacy of plans to include appropriate subjects, all
racial and ethnic groups (and subgroups), and children, as appropriate for
the scientific goals of the research. Plans for the recruitment and
retention of subjects will also be evaluated. (See Inclusion Criteria
included in the section on Federal Citations, below)
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: September 16, 2002
Application Receipt Date: October 16, 2002
Peer Review Date: February/March 2003
Council Review: June 2003
Earliest Anticipated Start Date: September 1, 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities
o Sufficient compatibility of features to enhance the likelihood of a
successful collaborative program
REQUIRED FEDERAL CITATIONS
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html), a complete copy of the updated Guidelines is
available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research, updated racial and ethnic categories in compliance with the new OMB
standards, clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398, and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable,
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
BAN ON FUNDING OF HUMAN EMBRYO RESEARCH: In accord with directives derived
from H.R. 2264 and S. 1061 and (Section 510) and included in the Labor, HHS
and Education Fiscal Year 2002 Omnibus Appropriations Bill enacted into law
(Public Law 107-116) on January 10,2002, funds provided for awards must only
be used in compliance with the following directive:
This section (510) continues the current ban that prohibits NIH from using
appropriated funds to support human embryo research. Grant, cooperative
agreement and contract funds may not be used for 1) the creation of a human
embryo or embryos for research purposes, or (2) research in which a human
embryo or embryos are destroyed, discarded, or knowingly subjected to risk of
injury or death greater than that allowed for research on fetuses in utero
under 45 CFR 46.208(a)(2) and section 498(b) of the Public Health Service Act
(42 U.S.C. 289g(b)). For purposes of this section, the term "human embryo"
or "embryos" includes any organism not protected as a human subject under 45
CFR 46 as of the date of the enactment of this Act, that is derived by
fertilization, parthenogenesis, cloning, or any other means from one or more
human gametes or human diploid cells. You will find this policy announcement
in the NIH Guide for Grants and Contracts Announcement, dated January 25,
2002, at http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-02-029.html
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
RFA is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.864, Population Research and is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and administered under NIH grants policies described at
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.